Paediaric French Committee Coordinator with Jean-Louis Bernard

Transcription

1 Including children in clinical trials Chantal Aubert-Fourmy Paediaric French Committee Coordinator with Jean-Louis Bernard European guidelines (2008) Because of the special protection they deserve, children should not be the subject of clinical trials when the research can be done in legally competent subjects... If research with children proves necessary, the least vulnerable among them should usually be included (i.e. older children)...the choice of subsets of the paediatric population to be included should be made on the basis of the likely target population for the medicine being tested, the possibility of extrapolation, and the scientific validity of such an approach. 2 Commission de pédiatrie Conférence Nationale des Comités de Protection des Personnes

2 The french Law(2004) Minors can be called on to participate to a clinical trial "des recherches d une efficacité Faux comparable ne peuvent être only if similareffectuées efficiency sur des personnes trials cannot be implemented majeures" with adults and in the following conditions: Vrai "l importance du bénéfice escompté pour ces personnes est de nature à justifier le risque prévisible encouru" Or the importance of the expected benefit for these Faux persons justifies the predictable incurred risk Or the trials are justified with regard ti predictable "ces recherches se justifient au Faux regard du bénéfice escompté pour Vrai benefits for other minors. In this case, the predictable d'autres mineurs" risks andillégal strains must be minimal. Vrai Légal 3 Commission de pédiatrie Conférence Nationale des Comités de Protection des Personnes Conclusion The objective of a trial is to increase knowledge, not to provide specific care to a small population. In case of trial including both adults and children, a specific analysis must be done in each population. 4 Commission de pédiatrie Conférence Nationale des Comités de Protection des Personnes

3 CLINICAL TRIALS CONDUCTED WITH CHILDREN: FROM INFORMATION TO ASSENT AND RIGHT TO REFUSE Chantal Aubert-Fourmy Paediaric French Committee Coordinator With Jean-Louis Bernard The Declaration of Helsinki (1964) When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 3

4 The first french Law on clinical trials (1988) Loi Huriet-Sérusclat " Minor s consent must be sought when able to express his will. His refusal or withdrawal of consent cannot be overridden. The french lawyer kept this formulation in the European directive s transposition in The right to refuse for a child is unconditional The Clinical Trials Directive (2001) "des recherches d une efficacité...the Fauxminor has received information comparable ne peuvent être effectuées sur des personnes majeures" according to its capacity of understanding, Vrai from staff of experience with minors, "l importance du bénéfice escompté pour ces personnes est de nature à Vrai justifier le risque prévisible encouru" regarding the trial, the risks and the benefits... Faux "ces recherches se justifient au regard du bénéfice escompté pour d'autres mineurs" Illégal Légal...the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the Faux Vrai 4

5 European guidelines (2008) Separate information sheets for adults and children, and separate consent and assent forms should be used in order to provide age appropriate information Difference of opinion between the child and the parents / legal representative Every effort should be made to understand and respect differences of opinion between the child and his/her parents or legal representative. Strong and definitive Conclusion The child s will is more and more respected with new regulations. French Law, since 1988 and still nowadays, gives more importance to the right to refuse of children, as there is no condition permitting to override it. 5

6 Child s information about Ethics Committee? Child s information about Ethics Committee 6

7 Child s information about Ethics Committee Child s information about Ethics Committee 7

8 Conférence nationale des Comités de protection des personnes Commission de pédiatrie Chantal Aubert-Fourmy and Jean-Louis Bernard Coordinators 8